Clinical Evidence for the Role of a Topical Anti-Inflammatory Agent in Comedonal Acne: Findings From a Randomized Study of Dapsone Gel 5% in Combination With Tazarotene Cream 0.1% in Patients With Acne Vulgaris

July 2011 | Volume 10 | Issue 7 | Original Article | 783 | Copyright © July 2011

Emil Tanghetti MD,a Sunil Dhawan MD,b Lawrence Green MD,c Mark Ling MD PhD,d Jeanine Downie MD,e Marguerite A. Germain MD,f J. Scott Kasteler MD,g Leon Kircik MD,h Michael G. Oefelein MD,i Zoe Draelos MDj

aCenter for Dermatology and Laser Surgery, Sacramento, CA bCenter for Dermatology, Cosmetic and Laser Surgery, Fremont, CA cDepartment of Dermatology, George Washington University, Washington, DC dMedaPhase, Inc., Newnan, GA eImage Dermatology PC, Montclair, NJ fGermain Dermatology, Mt. Pleasant, SC gDivision of Dermatology, University of Louisville, Louisville, KY hPhysicians Skin Care PLLC, Louisville, KY iAllergan, Inc., Irvine, CA jDepartment of Dermatology, Duke University School of Medicine, Durham, NC


Background: Acne pathogenesis is multifactorial and includes inflammation. Combining drugs targeting multiple components of acne pathogenesis is standard practice.
Objective: To assess the safety and efficacy of dapsone gel 5%, an anti-inflammatory agent, in combination with tazarotene cream 0.1% for treatment of acne vulgaris.
Methods: Patients were randomized to receive combination therapy (dapsone gel 5% twice-daily plus tazarotene cream 0.1% daily) or monotherapy (tazarotene cream 0.1% daily). Efficacy and safety data were collected after 1, 2, 4, 8, and 12 weeks of treatment.
Results: Patients in both arms (n=86, dapsone + tazarotene; n=85, tazarotene) showed significant reductions from baseline in inflammatory, noninflammatory and total lesion counts (P<.001 for all). At 12 weeks, patients treated with dapsone plus tazarotene showed a greater reduction from baseline in noninflammatory (comedonal) and total lesion counts than tazarotene-treated patients (noninflammatory, 59.7 percent vs. 46.5 percent, P=.01; total, 63.3% vs. 53.6%, P=.02). The percentage of patients achieving treatment success (an investigator subjective score of 0 [none] or 1 [minimal]) was greater in dapsone plus tazarotene-treated patients (42.2%) than in tazarotene-treated patients (21.8%;P=.01). Both treatments were well tolerated.
Conclusion: Combination therapy with dapsone gel 5% plus tazarotene cream 0.1% was more effective than tazarotene monotherapy for treatment of comedonal acne. The results suggest that anti-inflammatory agents such as dapsone can effectively treat early stages of acne (both comedonal and noncomedonal) when used in combination with a retinoid.

J Drugs Dermatol. 2011;10(7):783-792.


Acne, a common condition that can persist for years beyond adolescence,1 may result in scarring and post-inflammatory hyperpigmentation (PIH).2 The pathogenesis of acne is multifactorial and still not fully understood. Current dogma for acne pathogenesis suggests that follicular hyperkeratinization, abnormal epithelial desquamation and sebaceous gland hyperplasia lead to microcomedo formation. Continuous accumulation of sebum and deposition of keratinous material lead to development of lesions (open and closed comedones) traditionally classified as noninflammatory or, with proliferation of Propionibacterium acnes and induction of immunomodulatory events, inflammatory lesions.3,4